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J Am Coll Cardiol, 2006; 47:804-808, doi:10.1016/j.jacc.2005.09.058 (Published online 6 February 2006).
© 2006 by the American College of Cardiology Foundation
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CLINICAL RESEARCH: COAGULATION

The Risk of Hemorrhage Among Patients With Warfarin-Associated Coagulopathy

David A. Garcia, MD*,*, Susan Regan, PhD{dagger}, Mark Crowther, MD{ddagger} and Elaine M. Hylek, MD, MPH§

* Department of Medicine, University of New Mexico, Albuquerque, New Mexico
{dagger} Department of Medicine, Massachusetts General Hospital, Harvard Medical School, Boston, Massachusetts
{ddagger} Department of Medicine, McMaster University, Hamilton, Ontario, Canada
§ Department of Medicine, General Internal Medicine Research Unit, Boston University School of Medicine, Boston Medical Center, Boston, Massachusetts

Manuscript received July 1, 2005; revised manuscript received September 8, 2005, accepted September 13, 2005.

* Reprint requests and correspondence: Dr. David A. Garcia, 2211 Lomas Northeast, MSC10 5550, Albuquerque, New Mexico 87131. (Email: davgarcia{at}salud.unm.edu).

OBJECTIVES: Among warfarin-treated patients with international normalized ratio (INR) >5, we sought to determine the risk of major bleeding within 30 days.

BACKGROUND: For warfarin-treated patients, the risk of bleeding increases as the INR rises, particularly if the INR exceeds 4. The 30-day risk of hemorrhage among outpatients with excessively prolonged INR values is unknown.

METHODS: To assess anticoagulation care in the U.S., a cohort of 6,761 patients taking warfarin was prospectively assembled from 101 participating sites (43% were community-based cardiology practices). From this cohort, 1,104 patients were identified with a first episode of INR >5.

RESULTS: A total of 979 met eligibility criteria; complete follow-up information was available for 976 (99.7%). Ninety-six percent (n = 937) of patients had an INR value between 5 and 9; 80% of INR values were <7. Thirteen patients (1.3%) experienced major hemorrhage during the 30-day follow-up period; among patients whose INR was >5 and <9, 0.96% experienced major hemorrhage. None of the bleeding events was fatal. Intervention with vitamin K was uncommon (8.7%). Warfarin doses were withheld for the majority of patients. Fifty percent of patients who were managed conservatively and retested on day 4 or 5 had an INR of 2.0 or less.

CONCLUSIONS: For warfarin-treated outpatients presenting with an INR >5 and <9, the 30-day risk of major bleeding is low (0.96%). Intervention with vitamin K among asymptomatic patients presenting with an INR <9 is not routine practice in the U.S.




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